View clinical trials related to Atherosclerosis.
Filter by:The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
Although the clinical efficacy of LDL-cholesterol lowering therapy has been proven with strong evidences and emphasized, there are also growing concerns that intensive lipid-lowering therapy would be related to increased risk of adverse effects. In addition, statin potency from recent guidelines was set from the studies composed of mainly Caucasian population, although there is an inconsistency of statin effect according to ethnicity. Asian population showed more profound LDL reduction not only from high potent statin but also from moderate to low potent statin. Conventional strategies for lowering LDL-cholesterol focused on statins, therefore doubling of previously described dose of statin would be common way in patients with inadequate LDL-cholesterol levels. Adding ezetimibe will be an alternative strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of high-intensity statin to achieve sufficient LDL-cholesterol lowering effect. However, studies regarding the effect of intensive-targeting of lipid-lowering therapy and therapy regimens are lacking. Thus, on these basis, we sought to evaluate whether intensive-targeting of lipid-lowering therapy will have more prominent beneficial effect compared to conventional-targeting in patients with documented ASCVD with either an ezetimibe/statin combination therapy or a statin monotherapy.
The investigators propose a prospective, randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the safety and efficacy of an anti-inflammatory agent methotrexate in a cholesterol-rich non-protein nanoparticle (MTX-LDE) in patients with stable coronary disease. Patients with multi-vessels stable coronary disease will be randomized to receive MTX-LDE IV or placebo-LDE IV each 7 days for 12 weeks. The primary and main secondary endpoints will be analyzed by coronary and aortic CT angiography, that will be performed before the first treatment cycle, four weeks after the last drug infusion and 12 months after randomization. Patients will undergo clinical and laboratory safety evaluations before each treatment cycle, four weeks after the last cycle and 12 months after randomization. An algorithm for drug suspension based on clinical and laboratory finding will be followed.
This study is aimed to depict the epidemiological trend, aetiologies, clinical characteristics, treatment options of IS-NOAC in face of the rapidly increasing NOAC usage. Knowledge on this ischaemic stroke entity will define clinical characteristics, identify preventable causes and inform resource allocation on the evaluation modalities, reperfusion strategies and forecast future burden of IS-NOAC.
A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2 years follow up (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Another possible solution to the problem of stent breakage in the femoral-popliteal position is fasciotomy in Gunter's canal with dissection of the lamina vasto-adductoria. According to a pilot randomized study (Karpenko et al, 2019), the primary patency at 24 months was 60% in the stenting group supplemented with fasciotomy in Gunter's canal, and 28.5% in the stenting group without fasciotomy. These facts prove the need for a comparative study on a cohort of patients using a biomimetic interwoven nitinol stent. This is a pilot prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two methods of treating prolonged atherosclerotic lesions (TASC II, type D) of the arteries of the femoropopliteal segment above the knee.
Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Some studies with intervowen nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was > 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (>200 mm). This is a prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure. It is planned to recruit 110 patients (55 patients in each group). Observation period 2 years. Primary endpoint: -The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency). Secondary endpoints: - Clinical efficacy of the method of surgical treatment after 24 months (MALE); - Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE); - Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire); - Evaluation of prognostic factors for adverse outcomes after surgical treatment.
The objective of this study is to validate 2 multi-contrast sequences, namely the Multi-contrast ATherosclerosis Characterization (MATCH) and Bright-blood and black-blOOd phase SensiTive (BOOST) inversion recovery sequence for the quantification of atherosclerotic plaque components with conventional multi-sequence MRI and histology.
A prospective, single center, single arm non-randomized trial collecting safety and effectiveness data for the ABLUMINUS DES System to treat BTK lesions in subjects with CLI.
The OPTIMAL is a single-center, randomized trial to evaluate the efficacy of CGM-based glycemic control on atheroma progression in T2DM patients with CAD by using serial intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) imaging. A total of 90 eligible subjects will be randomized 1:1 into 2 groups to receive either CGM-based glycemic control or HbA1c-baded glycemic management. Coronary angiography and NIRS/IVUS imaging is repeated at the end of the assigned treatment period. Results: The primary endpoint is the normalized absolute change in total atheroma volume from baseline to 12 months. The secondary endpoints include (1) the absolute change in percent atheroma volume, (2) the percent change in lipid core burden index, (3) the change in coefficient variance measured by CGM, (4) the change in atherogenic markers (high-density lipoprotein functionality, proprotein convertase subxilisin/kexin type 9 and fatty-acid binding proteins), and (5) the frequency of hypoglycemia. Safety will also be evaluated.
Stroke is a common clinical disease with high disability and mortality, which seriously threatens human life and health.Carotid atherosclerotic plaque rupture is an important pathogenic basis of ischemic stroke, so judging the stability of plaque has important clinical significance in preventing ischemic stroke.Ultrasound, as a convenient, rapid, noninvasive, radiation-free auxiliary examination technology, is widely used in carotid plaque stability examination.At present, there are many methods to judge the stability of carotid plaque based on ultrasound, including two-dimensional ultrasound, contrast-enhanced ultrasound, ultrasound elastography and so on. However, the results of plaque stability judgment by various technologies deviate greatly, which is not conducive to the development of standardized diagnosis and treatment strategies by clinicians.Studies have shown that because the neovascular epidermal cells in atherosclerotic plaques are imperfect, they are easy to rupture after stress, and the ruptured neovasculature will lead to intraplaque hemorrhage, thus causing plaque shedding, and eventually obstructing the cerebrovascular cause stroke.Contrast-enhanced ultrasound can sensitively detect the distribution and course of blood vessels.The plaque's softness and hardness determine its stability, while the difference of lipids, fibers and calcium in the plaque determines its softness and hardness.Real-time ultrasound elastography can provide tissue mechanical parameters, express the soft and hard of tissue with strain value, and provide important reference information for judging plaque stability.At present, elastography technology is used to reflect the hardness of plaque, so as to further judge its stability.However, the elastography parameters are prone to deviations due to the influence of the selected section and the selected region of interest.Deep learning is the hottest research method in AI at present. [Deep learning is essentially to construct machine learning models with multiple hidden layers, and use large-scale data to train to obtain a large number of more representative feature information, so as to use these features to classify and predict samples. At present, it is widely used in the field of image analysis and plays an important role in medicine.Such as pathological image detection, regulatory genomics research, diagnosis of retinopathy and quantitative analysis of liver fibrosis, etc.Computational Fluid Dynamics (CFD) is a new discipline developed by the combination of numerical calculation and classical fluid mechanics theory. It can make it convenient for researchers to build a geometric model of cardiovascular system, simulate the real structure of vascular wall and blood, and display the results of "numerical experiments" using visualization technology.More intuitive Comprehensive response to changes in hemodynamic parameters In recent years, its application in cardiovascular hemodynamic research has become increasingly widespread, with a large number of relevant literature reports However, no report has been reported on the study of carotid plaque stability and fluid dynamics using this technology Based on the above reasons,This study attempts to use AI technology to automatically identify and quantitatively evaluate the gray scale differences of plaques, elastic image characteristics of plaques, microvessel density division of plaque contrast-enhanced ultrasound, and velocity vector imaging (VVI) to determine plaque surface stress.To study the effect of hemodynamic parameters on carotid plaque using CFD technology, and to establish a systematic comprehensive evaluation system for carotid plaque stability, which integrates two-dimensional plaque information, texture information, microcirculation perfusion information, biomechanical information and blood flow field information, and combines the results of clinical follow-up and collagen fiber content of surgical specimens, MMP9/CD34 and other examinations.